What must manufacturers follow to market their drug without FDA new drug approval?

To market a drug without undergoing the full FDA new drug approval process, manufacturers must adhere to monograph requirements. A drug monograph is a standard that outlines specific criteria that must be met by over-the-counter medications to be considered safe and effective. This includes detailed information on active ingredients, dosage forms, labeling, and the specific conditions for use.

By following these monograph requirements, manufacturers can demonstrate that their product conforms to established safety and efficacy standards without needing to go through the lengthy and rigorous process of a new drug application (NDA). This approach allows for more efficient entry of certain products into the market, especially for common, well-understood medications that meet pre-existing criteria.

While testing requirements, therapeutic guidelines, and generic regulations play important roles in drug development and innovation, they do not directly pertain to the pathway for marketing a drug under a monograph. Understanding this distinction is crucial for recognizing how certain medications can reach consumers without the extensive approval process generally needed for new drugs.